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Clinical chemistry biological screening IVDs - ARTG 445592

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 445592 and sponsored by 2San Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd (China) in China. The device registration started on April 10, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 445592
Class IIa
Clinical chemistry biological screening IVDs
ARTG ID: 445592
Good Name: 2San Pty Ltd - Clinical chemistry biological screening IVDs
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DJ Fang

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Intended Purpose

Vaginal PH:The Vaginal pH Rapid Test Panel (Vaginal Swab) is a rapid dry chemical method for the semi-quantitative detection of pH in female vaginal swab specimens to aid in the diagnosis of bacterial vaginosis. UTI: The Urinary Tract Infections Test (Urine) compromises firm plastic strips onto which several separate reagents are affixed. The test is for the qualitative detection following analytes in urine: Leukocytes, Blood, Nitrite and Protein. The Urinary Tract Infections Test (Urine) is for single use in self-testing.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
445592
Start Date
April 10, 2024
Effective Date
April 10, 2024
Sponsor
Manufacturer
Country
China
Address
550# Yinhai Street Hangzhou Economic and Technological Development Area, Hangzhou, 310018